Senior Regulatory Affairs Specialist - Galway, Ireland - Medtronic

Description

Senior Regulatory Affairs Specialist - Peripheral Vascular Health (hybrid)

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Peripheral Vascular Health therapies treat patients with Peripheral and Carotid Artery Disease, End-Stage Renal Disease, Superficial and Deep Venous Diseases, and a variety of conditions treated with Peripheral Embolization. The operating unit leads the way in the Superficial Venous, Deep Venous Stenting, AV Access and Drug-Coated Balloon markets, caring for over 1 million patients globally with lifesaving and life-enhancing therapies.

Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Career That Change Lives

The Senior Regulatory Affairs Specialist (Sr. RAS) develops and executes strategies for global regulatory approvals to introduce new and modified medical devices to the market for the PVH business. The Sr. RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required. Primary responsibilities include: developing global regulatory strategies; preparing US, EU and international regulatory submissions; providing documentation for international submissions; supporting post-market regulatory compliance activities; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables. This role focuses on regulatory support for global markets, with a wide variety of regulatory tasks to allow you to make the most of your existing knowledge base while growing your RA skill set every day. In this role, you will have primary RA responsibility for multiple Class II products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.

From developing and authoring regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the world's leading medical device company.

This role will be based in either Minneapolis, MN or Galway, Ireland.

A Day In The Life

Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA and other worldwide government agencies. Able to write regulatory justifications to support submission filing decisions.

Leads or compiles all materials required in submissions, license renewal and annual registrations.

Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.

Interact with regulatory authorities during the development and review process to ensure submission approval.

May be included as RA Representative on project teams with members of development project teams as necessary to communicate regulatory submissions requirements and preparations according to a defined timeline.

Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

Review and approve RAC's, RAN's, NCR's, product labeling and promotional materials, per company procedures, to assure compliance with regulatory requirements.

Maintain current knowledge of the development and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals with the company.

Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.

May recommend strategies for earliest possible approvals of clinical trial applications.

Other duties as assigned.

Must Have; Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

Nice To Have